Class II · Moderate risk Terminated
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
What was recalled
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
- Recalling firm
- Akron Pharma, Inc.
- NDC code
- 71399-2829-1
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0454-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dibucaine recalls
See all
Class III · Low risk Terminated
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
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